Some research studies require extensive information documents due to the procedures and/or known or anticipated risks.
The informed consent process begins at the recruitment stage and continues through to step of providing appreciation and feedback on the study findings.
A few special considerations are:
Web-based questionnaire studies introduce different requirements to ensure anonymity of participants such as: the site will not collect any information that could potentially identify participants (such as IP addresses or machine identifiers).
Some types of interview studies cannot provide anonymity due to the nature of the research such as a oral history. In some studies attribution may enhance the research while anonymity would detract from it.
Written consent
Once a potential participant has read the information letter and has had an opportunity to ask any questions related to the study and receive satisfactory responses, they should requested to sign a consent form that states they have read the information in the letter and agree to participate in the research.
Verbal or oral consent
For some groups (e.g., ethnic, cultural) or situations the information letter contents may be presented verbally.
Implied consent
If a project involves an anonymous questionnaire a consent form is not necessary since consent is implied by the participant completing and returning the questionnaire.
For studies where there is a possibility that a researcher may learn that a participant may do harm to his/herself or another, then the information letter should reflect the researcher's legal obligations and should include an exception clause to the confidentiality of data statement.
For example: "All information you provide will be kept confidential except as required under law".
If the project involves school children then the statement could be " In cases where researchers believe that a student may need protection from harm, researchers must by law report this information to authorities. "
The following set of questions can be used as a guide for research participants in seeking information about a study.
These questions can also serve as an outline for the type of information to be provided to a research participant during the informed consent process.
In addition, these questions can be used in the development of an Information Letter with Question and Answer format. Also, refer to the checklist for creating an information letter and consent form (DOC) .